Safety Study of Parathyroid Hormone in Patients Needing Additional Stem Cell Mobilization.

This study has been completed.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00299780
First received: March 3, 2006
Last updated: April 23, 2007
Last verified: April 2007

March 3, 2006
April 23, 2007
July 2004
Not Provided
To assess safety of parathyroid hormone in combination with G-CSF when used as a mobilization agent at four different dosing levels.
Same as current
Complete list of historical versions of study NCT00299780 on ClinicalTrials.gov Archive Site
  • To evaluate the peripheral blood CD34+ count after second mobilization.
  • To evaluate CD34+ cells/kg from apheresis after second mobilization.
  • To evaluate the percent of patients for whom adequate numbers of CD34+ cells are obtained.
  • To evaluate transfusion support.
  • To evaluate the days to neutrophil engraftment (ANC >500) post autologous transplant.
  • To evaluate the days to platelet engraftment (platelet count > 20,000 unsupported).
Same as current
Not Provided
Not Provided
 
Safety Study of Parathyroid Hormone in Patients Needing Additional Stem Cell Mobilization.
Phase I Study of Parathyroid Hormone in Combination With G-CSF in Patients Requiring Additional Stem Cell Mobilization

The purpose of this study is to determine the safety of parathyroid hormone in combination with G-CSF when used as a stem cell mobilization regimen for patients who fail to mobilize sufficient progenitor stem cells after one or two attempts.

Patients will start treatment within 21 days of the determination of inadequate mobilization. PTH treatment will be given in 4 cohorts: 40 mcg, 60 mcg, 80 mcg, and 10 mcg. PTH will be given on day 1 and continue until stem cell collections are complete or a maximum of 20 days. G-CSF 10 mcg/kg will be given on days 10-14 and continue until stem cell collections are complete. Patients with inadequate CD34+ cells on Day 14 will meet off study criteria and not continue with PTH/G-CSF.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoma
  • Multiple Myeloma
  • Acute Myelogenous Leukemia
Drug: Stem cell mobilization
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
April 2007
Not Provided

Inclusion Criteria:

  • Disease status: NHL or HD refractory to chemotherapy, relapsed, o high risk first remission; multiple myeloma; AML in second or subsequent remission or in first remission with adverse cytogenetics or antecedent hematologic disorder.
  • Failed one or two mobilization attempts.
  • ECOG performance status of 0, 1, or 2.

Exclusion Criteria:

  • Cardiac disease: symptomatic congestive heart failure, angina pectoris or uncontrolled hypertension
  • Pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease.
  • Renal disease: serum creatinine > 2 mg/dl
  • Hepatic disease: SGOT or SGPT > 3x normal; serum bilirubin > 2.0 mg/dl that is not due to Gilbert's syndrome or hemolysis
  • Calcium > 10.5
  • Phosphate < 1.6
  • Uncontrolled infection
  • Pregnancy or breast feeding mother
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00299780
04-109
Yes
Not Provided
Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • Beth Israel Deaconess Medical Center
Principal Investigator: Karen Ballen, M.D. Massachusetts General Hospital, Harvard University
Massachusetts General Hospital
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP